\nThe Role:\n\nReporting to the VP Finance, this position is responsible for the controller group, producing accurate and timely financial statements, overseeing the close process and all other accounting responsibilities such as T&E, chart of accounts etc. The Controller will be the ultimate reviewer of the CRO and CMO accruals. This role requires strong managerial capabilities to drive process improvement, system implementations and employee development.\n\nKey Responsibilities: \n\n\n* Finalize accurate and timely monthly, quarterly and annual financial statements (balance sheet and statement of income) in accordance with GAAP. Design and manage the monthly close process to ensure timely and accurate financial statements.\n\n* Design, implement and maintain a system of internal controls to ensure safeguarding of Company assets and accurate financial statements.\n\n* Establish and enforce accounting policies and procedures and operational strategies including the review and implementation of process and system improvements.\n\n* Ultimate reviewer of CRO and CMO accruals, overseeing improvements to CRO and CMO accruals processes to support growth of the business.\n\n* Manage a team including multiple direct reports and a larger group of indirect reports ensuring appropriate allocation of responsibilities and sufficient back-up support.\n\n* Serving as principal contact with independent auditors.\n\n\n\n\nRequirements:\n\n\n* Bachelor’s degree in accounting and Certified Public Accountant.\n\n* 15+ years of experience - some in public accounting (big four), at least 10 years of experience in the biotech industry and at least 6 years of experience as a controller.\n\n\n\n\n\n* Experience with financial reporting at a publicly traded company.\n\n* Experience with CRO and CMO +accruals is a must.\n\n* Demonstrated ability to organize an efficient and effective monthly closing process.\n\n* Demonstrated ability to work in a dynamic and rapidly changing environment and the flexibility to handle multiple priorities simultaneously.\n\n* Team player, able to garner the respect of direct reports, peers, and superiors throughout the organization.\n\n* Strong communications and analytical skills.\n\n* Experience with NetSuite, Coupa, Expensify, Auxilius/Condor is preferred.\n\n\n\n\nWork Environment:\n\n\n* Remote-based\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment\n\n* Domestic or international travel are required (20%)\n\n\n\n\n \n\nCompensation is based on several factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity, sign-on bonuses, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave. The annual base salary for this position ranges from $250,000.00 - $265,000.00.\n\n  \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Design, Travel, Accounting and Senior jobs that are similar:\n\n $82,500 — $155,000/year\n
\n\n#Benefits\n 💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n

\nAbout Prilenia \nPrilenia Therapeutics, a clinical-stage biotech company focused on the urgent mission of developing novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, is looking for a Senior/Executive Director of Quality to join its team in Europe. \n\n\nWe are a flexible, fast-moving team that is quickly advancing a potential therapy poised to have major impact on the lives of patients and their families. Our lead product candidate, pridopidine, holds Orphan Drug Designation in both Huntington’s disease (HD) and Amyotrophic lateral Sclerosis Amyotrophic (ALS) in the U.S. and EU, as well as Fast Track designation from the FDA for the treatment of HD. Prilenia is working on preparing for a potential regulatory filing for HD and for starting a global phase 3 in ALS with pridopidine.\n\n\nPridopidine has the potential to be the first treatment to address HD disease clinical progression. Prilenia also believes pridopidine’s novel mechanism of action as a Sigma-1 receptor agonist gives it potential in numerous other neurological diseases. \n \nAbout the role\nWe seek a highly qualified and experienced professional to join our team as the Head of Quality. This position will provide both overall direction and hands-on operational execution in establishing, implementing, and maintaining a phase-appropriate and continuously evolving Quality Management System (QMS). The ideal candidate will have background in late clinical stage and first commercialization of products including GCP, GMP, GVP and other relevant GxP, with a pragmatic true fit-for-purpose approach.\nThe position will report to the Chief Operating Officer.\n\n\n\nRoles and Responsibilities:\n* Lead the development, implementation, and continuous improvement of a phase-appropriate Quality Management System (QMS), including policies, processes, and procedures.\n* Collaborate with internal functions to assure effective vendor selection, qualification, and oversight to ensure clinical trials and other outsourced GxP activities are conducted in accordance with all relevant laws, regulations, and guidelines.\n*   Assess GMP and regulatory compliance risk areas and develop and implement risk mitigation measures.\n* Create, implement, and oversee audit plans for CROs, CDMOs and other GxP vendors. Assess and respond to audit outcomes.\n* Lead preparations for regulatory inspections and ensure ongoing inspection readiness.\n* Provide  GCP advice and audit for clinical studies to ensure they are conducted in accordance with FDA, EMA, ICH and other applicable requirements, guidelines and laws.\n* Identify any training requirements to meet the quality standards and ensure training is completed.\n* Maintain and expand regulatory knowledge, to the ICH Principles of GCP, GMP, General Data Privacy Regulation and International GxPs; provide industry leading compliance guidance and quality assurance consultation to internal and external stakeholders.\n* Manage all relevant external QA vendors e.g. quality auditors, consultants, etc.\n\n\n\nQualifications:\n* 10+ years of experience in QA roles with a mix of Biotechnology/Pharmaceutical and/or CMO/CRO companies.  At least part of the time should have been in a small to medium sized biotech or pharma company.\n* In-depth understanding and application of GxP principles, concepts, practices, and standards.\n* Demonstrated experience in establishing and managing quality systems in small to mid-sized companies.\n* Thorough understanding of GCP and GMP standards for late clinical and early commercialization stages; as well as of both US and EU requirements. \n* Prior experience and broad range of knowledge in Quality, Compliance, or a combination of experience such as Manufacturing, Quality, and Regulatory - required. In-depth knowledge in international regulatory landscape - preferred.\n* Proven experience in building key metrics, reporting, and enhancing recruitment technology and systems to influence decision-making and provide compelling story telling.\n\n\n\nSkills:\n* Excellent oral, written and interpersonal communications skills to effectively interact, and exercise discretion, judgment and diplomacy when dealing with internal and external stakeholders and executive leadership. \n* Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality, and risk. Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.\n* Pragmatic and practical approach; understanding of “fit for purpose” approach. \n* Team player with positive attitude who can easily handle shifting priorities, multi-tasking in a deadline-oriented environment. Must be able to work under pressure, manage time, set priorities and meet deadlines.\n* Highly independent.  \n* Experience working in virtual and global setting.\n* Ability to take initiative, be accountable for individual and team results, motivate self and others to set and achieve very high-performance standards.\n\n\n\nLocation/Time Zones:\n* This is a full-time remote position in Europe. \n* Flexible schedule with interactions across Israel, North America and Europe time zones.\n* Occasional travel is expected.\n\n\n\n\n \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Senior and Senior jobs that are similar:\n\n $40,000 — $80,000/year\n
\n\n#Benefits\n 💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nEurope

\nOur mission is to develop therapies that empower the immune system to combat neurodegeneration and our team is focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, a novel portfolio of programs, leading healthcare investors, and pharma company partners, who share in our commitment to bettering the lives of patients and realizing a world where we make brain disorders history \n\n\nWe are looking for a Senior Director, Biostatistics, reporting to the VP of Biostatistics and Analytical Programming. As the Biostatistics Senior Director, you will collaborate with R&D functions to support robust and efficient study designs, develop comprehensive analysis plans, and lead the delivery of study data analysis results. You will be the expert statistical leader providing oversight and strategic feedback for the clinical programs assigned to you. The Senior Director, Biostatistics, will drive the development and implementation of statistical strategy to effectively support drug development You will directly impact company success by increasing the strength of study designs, interpretability of results, Regulatory strategy & interactions, and by implementing innovative methods to improve efficiency & quality of clinical development.\n\n\n\n\n\nYour priorities will include:\n* As the lead Biostatistician for assigned projects and ensure effective, timely and compliant management and delivery of project goals and accountabilities.\n* Define the statistical strategy and ensure appropriate statistical methodologies are applied to study designs and data analyses for clinical trials.\n* Provide expert statistical input and consultancy to Phase I – IV global clinical trials, lifecycle management activities as well as translational medicine research efforts.\n* Ensure a high degree of rigor is applied to the statistical and scientific decision-making process and outcomes.\n* Collaborate with internal and external collaborators in study design, analysis, reporting, interpretation, and communication of clinical trial results.\n* Author and review critical documents such as briefing documents, protocols, SAP, top-line reports, CSR, and integrated summaries.\n* Support the project team and clinical study team including the derivation of go/no-go criteria, summary reports, and results interpretation.\n* Participate in FDA and other regulatory body interactions (IND/CTA filings, safety reporting).\n\n\n\nWe'd love to hear from you if you have:\n* Ph.D. in Statistics or related discipline with 10+ years, or MS with 15+ years of proven experience in the biotechnology or related industry, including interaction and submission experiences with both FDA and EMA.\n* Successful project and people management and expertise in the development of CNS diseases.\n* Thorough knowledge of life cycle management; consistent track record of innovatively applying statistical principles, theories, and concepts to clinical drug development leading to regulatory approvals.\n* Deep hands-on operational experiences in Biostatistics deliverables, including study design, protocol development, CRFs, clinical databases, Statistical Analysis Plans (SAP), SDTM/ADaM datasets, and CSR Tables/Figures/Listings.\n* Up to date knowledge of industry and academic developments in the Neuroscience, and apply them to clinical study design and analysis.\n* Demonstrated innovative and flexible ability and mindset to work in a changing and demanding environment. Exercise good judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards.\n* Demonstrated strong leadership, project management, collaboration, communication, and organization skills.\n* Advanced programming skills in SAS, R and other relevant statistical software solutions.\n* Detailed knowledge of adaptive designs, Bayesian methodology, trial simulation, and complex modeling.\n* Innovative problem-solving capabilities, the agility to respond promptly and completely to time-critical tasks.\n\n\n\n\n$250,000 - $290,000 a yearBase salary ranges will be determined by the candidate’s level, qualifications, skill set, and experience.\n\n#LI-BL1\n#LI-Remote\n\n\nAt Alector, our vision is bold, people are our priority, and our values are at the core of everything we do. Our dynamic and flexible environment encourages our teams to experiment, take ownership of decisions, and question convention to solve complex problems. We value shared wins, perseverance, and a growth mindset, which drives us forward, together.  \n\n\nAlector was named on Fortune’s "Best Workplaces in Biopharma" top list for small and medium-sized companies for the third consecutive year! And we moved up from #16 to #11 in 2022.  \nAmong the things you'll discover at Alectorfrom your very first day are our committed and driven colleagues, a bold company vision, and new, modern offices designed to inspire innovation and collaboration in South San Francisco, right at the heart of Biotech Bay. Our benefits are thoughtfully designed around Alectorians and their loved ones and include flexible hybrid work options, competitive compensation, and comprehensive and unique benefits that enhance your health and well-being. Come join us! \n \nWe believe that hard-working teams include people from a wide variety of backgrounds and experiences who can challenge each other’s assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristics protected under applicable federal, state, or local laws.  \n\n\nWe will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.  \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Design and Senior jobs that are similar:\n\n $45,000 — $85,000/year\n
\n\n#Benefits\n 💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nUnited States